On April 21, Solve ME/CFS Initiative hosted a webinar with Dr. Avindra Nath, NINDS intramural clinical director, and the lead investigator of NIH's ME/CFS study. (For those who missed it, the webinar will be available on theSolve CFS Youtube channel.)

The first half hour of the talk centered on the NIH study: how it will be structured, how patients will be selected, and how they will be tested. (This information has been presented elsewhere on this blog, so I will not summarize it here.)

In the second half hour, Dr. Nath responded to questions from the listeners, which Dr. Zaher Nahle, Solve ME/CFS Initiative's Vice President for Research and Scientific Programs, was kind enough to deliver.

The first question put to Dr. Nath concerned bias among people involved in the NIH study. The answer was "I can't give a litmus test to every researcher."

There was clearly a misunderstanding about the scope of the question, so Dr. Nahle rephrased the question to ask specifically about bias among the NIH staff. Once again, Dr. Nath responded by reducing the question to absurd proportions, claiming that he didn't have time for "psychological games."

Neither did Dr. Nath have time to talk to Drs. Fluge and Mella. "I can't talk to everyone who has done a study," is how he answered that question. Of course, Fluge and Mella aren't "everyone." The third phase of the NIH study will involve testing immunomodulatory drugs, one of which may be rituximab. Nobody knows more about the effects of rituximab on ME/CFS than Fluge and Mella, so one would think that a consultation would be prudent.

There was not much time for further questions, but I have no doubt that Dr. Nath would have sidestepped those as well.

Reductio ad Absurdum

In rhetoric, the device known as reductio ad absurdum is employed to avoid addressing an opponent's argument. By reducing an argument to absurd proportions, not only is a pall cast over the opponent's point, the discussion effectively comes to a halt.

Dr. Nath has demonstrated this technique on prior occasions.

During the NIH telebriefing, Charmian Proskauer, President of the Mass CFIDS/ME/FM Association asked if 40 patients were too few for the study. Dr. Nath replied "If you need to have a thousand patients to find something, it probably isn't worth finding." There are numbers, perfectly reasonable numbers, between 40 and 1000. One hundred, for example, is a reasonable number. But, by exaggerating Ms. Proskauer's argument. Dr. Nath neatly sidestepped the question of whether we really needed another pilot study.

In like fashion, "I can't talk to everybody" sidesteps the question of whether Dr. Nath will confer with two researchers involved in the only current large-scale study on a drug that has shown promise for ME/CFS patients.

As for the question of bias, "I can't do a litmus test on everybody," "I can't read minds to see who is biased," and "I don't have time for psychological games," are reductio ad absurdum arguments as well. Nobody has asked Dr. Nath to read anyone's mind. We have simply questioned the appropriateness of three (only three) staff members, two of whom are in key positions.

The true intent of reductio ad absurdum responses is to belittle the opponent. When this type of rhetorical strategy is employed, there can be no doubt that the person using it is not only seeking to avoid replying to a point, but to diminish the person making it. (Reductio ad absurdum is only one step removed from ad hominem attacks, which belittle the person directly. Both are considered logical fallacies.)

The questions posed to Dr. Nath today were phrased respectfully. They addressed concerns that should be taken seriously by anyone conducting a study at public expense. Public scrutiny is to be expected under these circumstances, and yet Dr. Nath appears to believe that we should not be looking at who performs the study, or examining the protocol, or, in fact, asking any questions at all.

Our tax dollars are paying for this study. It is not only our right to know what the federal government is spending our money on, it is an ethical duty on the part of the government to make full disclosure. Above all, a clinical trial should never be conducted in secrecy, for obvious reasons. And a trial that has even a remote possibility of bias or mismanagement should receive even more scrutiny. That is how good science is conducted.

Researchers who maintain an attitude of scorn towards the subjects of their studies rarely produce good research. And researchers who do not bother to thoroughly investigate prior as well as current research uniformly produce bad research. While Dr. Walitt has been open about his bias (even while denying that he has one), it is becoming increasingly clear that Dr. Nath's dismissive "I can't be bothered" attitude will be equally problematic in this study.

On March 29th 2016, the Dutch Health Council (the advisory body to Dutch Parliament) announced the names of the members of a newly formed Committee that has the important task to write an advisory report on the state of the scientific knowledge about ME for Dutch Parliament.

The idea for the Committee was initiated by ME patients themselves, who, after suffering decades of medical ignorance, requested acknowledgement by the government, as well as a scientific review of ME to support appropriate diagnosis and treatment.

As is often the case when a government has vested interests in maintaining the status quo, their efforts were co-opted. Half of the Committee members view ME as a psychosomatic illness. Some openly recommend GET and CBT as legitimate treatments for ME. Meanwhile, none of the international experts requested by Dutch ME patients has been included.

The petition “ME is geen SOLK”, which translates as “ME is not MUPS/Medically Unexplained Physical Symptoms” has been launched to redress the inequity of the Committee's composition:

That the Dutch Health Council was asked to take another look at the state of the scientific knowledge with respect to ME was a direct result of a well known Dutch Citizen’s Initiative “Erken ME”/Recognize ME.

This group of very ill ME patients was fed up with (the status quo and) the total lack of care and lack of knowledge about this disease with health care professionals in the Netherlands, the total lack ofbiomedical research in their country, as well as the huge influence of CBT/GET psychologists in the Netherlands (now joined by a growing number of psychologists who stand behind and actively promote MUPS diagnoses, theories and treatments for this patient group).

ME patients really have no place to go for care, they are only referred to CBT/GET treatments. The Dutch Health Council report in 2005 did not help, it was one of the reasons the CBT/GET paradigm has become so strong in the Netherlands, (as it is in the UK), almost all reasearch funds after the 2005 Health Council report was presented to Parliament went to CBT studies from Nijmegen/Radboud University, who over the years have worked closely with the PACE authors.

It prompted the Dutch Citizens’s Initiative (Burgerinitiatief) “Erken ME”/”Recogize ME” in 2011. It took more than 2 years. More than 56,000 signatures were collected and presented to Parliament in 2013. They were able (together with 2 ME experts, Prof. DeMeirleir and Dr. Klein, who are now not on the Committee) to convince Parliament members that something needed to change for ME patients in The Netherlands, that the scientific knowledge about this disease justifies a paradigm shift, in care and biomedical research. The result, an official request on April 9th 2015 from Parliament to the Dutch Health Council for a new advisory report on the state of the scientific knowledge with respect to ME.

Patient organizations and the Dutch Citizen’s Initiative urged the Dutch Health Council to seek international expertise for its Committee, as true expertise on this disease is lacking in the Netherlands. However, none of the international experts that were suggested to the Dutch Health Council were invited to join the Committee (even though these experts had already said to be willing to participate).

Now almost half of the Committee members are professionals with a clear SOLK/MUPS and CBT background. One member is a well known Dutch psychologist/“PACE colleague” from Nijmegen/Radboud University, head of the NKCV (Nijmegen Expert Centre for Chronic Fatigue).

They, for example, provided the protocol for CBT that was (partly) used in the PACE trial, and wrote the well known “Where to PACE from here” commentary that was published together with the original PACE study in 2011 in the Lancet. This commentary included some false/exaggerated “recovery” claims, which was pointed out in a recent letter from more than 40 experts to the Lancet

The 3 other members that patients are concerned about have a clear MUPS background. CFS, Fibromyalgia and IBS are mentioned as examples of MUPS (SOLK), by them. MUPS is becoming a new “diagnosis”, claimed by psychologists. MUPS “diagnoses” and treatments are linked to the wellknown underlying biopsychosocial model for MUPS (and CBT), which means patients need CBT and are referred to Mental Health Institutions to get those treatments. A nation wide project is set up (funded by health care insurers) to implement this on a large scale. The SOLK (MUPS) multidisciplinary and Somatoform Disorders guideline in the Netherlands, as well as a SOLK (MUPS) General Practitioners’ Standard (one of the Committee members was involved in writing both), lists CFS as an undifferentiated somatoform disorder (ICD F45). The Dutch “CVS”/CFS Guideline (now considered part of the SOLK guideline) was based on the NICE UK Guideline for CFS.

Patient organizations have refused to authorize it, yet CBT is promoted as the first choice of treatment for ME patients in the Netherlands. Other professionals with a SOLK (MUPS) background sometimes refer to CFS as a functional syndrome. The NKCV/Expert Centre for Chronic Fatigue (head Hans Knoop, a Committee member) also in several documents describes CFS as an undifferentiated somatoform disorder. The underlying theory of treatment options suggested by these professionals (CBT/GET), the biospychosocial model, is a theory that has never been proven, yet MUPS/SOLK/CBT professionals in the Netherlands claim that it is evidence based and often curative. Besides 4 MUPS/CBT members there are 4 other doctors on the Committee, only two have some experience with ME patients, others don’t.

This is why in the Netherlands patients feel so strongly about using the appropriate name and ICD classification for their disease; ME, ICD G93.3. There is a need to get ME out of the CFS umbrella, as suggested by the ICC authors in 2011 and the CFSAC (chronic fatigue syndrome advisory committee) in its recommendations to the HHS in 2015 (recommendations that were based on the IOM and NIH/P2P reports).

The name CFS is linked to inappropriate classifications for this disease and therefore gives a misrepresentation of what this disease is, i.e. the state of the science says. In their last report in 2005 on “CVS”/CFS the Dutch Health Council Committee also made a clear reference to both ICD F45 (somatoform disorders) and F48 (neurasthenia) as possible classifications for CFS (page 37). But then made the argument that too much focus on the issue of classification was not that important or helpful with respect to relevant treatments.

On page 37 of the 2005 Dutch Health Council report it states: “The Committee argues, however, that the place of CFS in a classification system says nothing about the nature of the illness and that the CFS case definition is no more than a description of a pattern of symptoms that cannot have any bearing on a discussion about whether it is ‘neurologic or psychiatric’. Furthermore, the Committee does not consider such a discussion to be helpful as far as the treatment of patients is concerned.”. An all too familiar argument still heard today by MUPS/CBT/mental health professionals working with CFS patients: it does not matter if this disease is physical or psychosomatic, they have a treatment that works, so let’s focus on that; …. CBT/GET.

The new report of the Dutch Health Council will be highly influencial with respect to health care policy for ME patients in the Netherlands in the next decade (and patients really were hoping for change to get the care they need an more biomedical research so that in time there might be a cure!). For ME patients in the Netherlands it is unacceptable that 10 years after the 2005 Health Council report, with all the available scientific knowledge about this disease and the clear assignment from Parliament to write an advisory report on the current state of the scientific knowledge about ME, for the Dutch Health Council to select a Committee with members that still stand behind the MUPS/CBT (biopsychosocial) theories (and classifications of CFS as MUPS, somatoform disorders etc.) when dealing with this neurological, chronic complex multisystem disease (ME, ICD G93.3).

Hence, the petition “ME is geen SOLK” (ME is not MUPS) was launched.

Patients cannot wait another decade for change! Time to put the biopsychosocial model behind us. We hope you will help Dutch patients by signing and sharing the petition (link).

A couple of months ago I discovered my friend Whitney had been bed-bound for over three years. His dad, Dr. Ron Davis, a scientist involved in the Human Genome Project, focused all of his time and effort in researching his son’s disease. I wanted to help, and thought, as a freelance writer, I could at least publish articles about Whitney to raise awareness, and decided I needed to see his house in person. My friends didn’t seem to understand.

I told someone about the time Whitney and I had together, and said it was the perfect summer romance: two kids, in Alaska, playing in fields with muskox and caribou.

“We had a month. Exactly a month. And he was leaving and we’d never see each other again,” I said. “So we had this month of intense connection without worrying about whether or not it’d turn into a relationship. We could just be with each other, and love each other as much as we wanted without any stress over the future.”

In going to visit a friend who’s sick, and telling people I’m doing so, most of the reactions are sad moans and frowns. When I said I wouldn’t be able to see him, they’d cock their head to the side a little and furrow their brows in confusion.

“He can’t tolerate anyone being in his room,” I tried to explain. “He’s too sick. He’ll crash if his brain is forced to process who I am and why I’m there. His body would shut down.”

“But I thought he only had chronic fatigue syndrome?”

I barely understood the science of it, or how it worked. The only way I could think of explaining it was that, even though he’d spent most of his time in bed for the last three years, it was more like he’d been resting with his eyes closed.

“Imagine how you’d feel if you hadn’t had any restorative type of sleep in three years. His entire body is so exhausted, any amount of energy output he’s not prepared for shuts him down to a hibernation-type of state.”

“From chronic fatigue syndrome?”

And so it goes. I can’t imagine what it’s like for patients to explain their daily lives to friends and family or doctors.

It was late at night when I pulled into the driveway of the house where Whitney grew up. Even though his parents, Janet and Ron, had left the door unlocked for me, I still felt like a stranger creeping into the house. It’d been over 13 years since I’d seen Whitney, 10 or 11 since we’d talked on the phone, and over a year since I’d received any kind of message from him. I walked in to find Ron in the kitchen. He smiled so broadly at me, I hugged him.

Ron and Janet’s nightly routine consists of quietly shuffling in and out of the back room where Whitney lives. The room he never leaves. He has to be prepared for them to enter the room, has to know when to expect them. Once inside, they work quickly to meet his needs then leave him be. On my first night at the house, I watched all of this with a mix of awe and helplessness.When I finally went to sleep in the living room, I could still hear Janet moving around in the kitchen.

I got up the next morning and followed Ron to his office at Stanford, which sits above a laboratory where dozens of scientists, students, and even three Nobel laureates work full-time to research ME/CFS. We walked through the building, and he pointed out work stations, robotic machines, and lab areas. As a writer, I was in a foreign land – math and science were areas I tried to avoid in college.

But sitting across from Ron at his desk upstairs, I shied a little, knowing I sat with a celebrity. Ron leads the Open Medicine Foundation as the scientific advisory board director, and is the Director of the Stanford Genome Technology Center. He is recognized as one of the leading scientists studying ME/CFS, and he fights daily to fund his research. “One of the scientists who works for me is retired, and volunteers their time,” he said. “What we need the most is funding.”

I looked down at Ron’s shoes. Whitney can’t tolerate seeing any kind of lettering at times, and Ron and Janet have to be careful to not wear clothing with any logos. On the front of Ron’s North Face, black sneakers, he’d carefully blacked out the lettering with permanent marker. It was the smallest effort that speaks to how he and Janet work diligently, changing every aspect of their life, tirelessly trying to find a cure for their son, and millions of others who suffer.

Tibetan prayer flags hang over Whitney’s door, above the porch, and all over the back stoop leading from Whitney’s room. When Janet took me out back to look at the forget-me-nots and African daisies Whitney had planted, she said he might be able to see me from the window. I got nervous and hopeful at the same time. I tried not to look in the direction of his room, but after a while I couldn’t help it. He’d planted my favorite flowers all over the yard, and they, along with the columbine he’d planted for his mom, were some of the only ones in bloom. In the backyard, Janet and I talked in whispers. I caught myself staring at the the back bedroom, at the walls that encased him. At the house that keeps him safe but imprisoned at the same time.

When I talk to Janet, I always tell her to send Whitney my love however she can. I can’t wait until the day I’m able to do it myself.

To donate to help Ron’s efforts with the Open Medicine Foundation, and further his much-needed research for a cure, go HERE.

About the author: Stephanie Land is a writing fellow for the Center for Community Change, and a board member at the Blue Ribbon Foundation. Her work has been featured through The New York Times, The Washington Post, and The Guardian. She lives in Missoula, Mont., with her two daughters. Read more of her story at stepville.com or follow her @stepville.

A few weeks ago I wrote a letter to the NIH ME/CFS Trans-NIH Working Group, stressing the fact that Dr. Walitt was not qualified to be Lead Clinical Investigator of the NIH study, or, for that matter, to be involved in the study in any capacity.

The Trans-NIH Working Group PR department has finally written me back.

It was a letter filled with reassurances designed to quell rather than to inform. I have no doubt that the person who wrote it hasn't the faintest idea what the study is about, or who Dr. Walitt is.

NIH has said that it is open to input from patients. But if their policy is to respond to our concerns with stock replies from their PR staff, what does that say about the value they place on our input? It is a hollow gesture to offer an open door, only to have it lead to an empty room.

This was my reply to the letter I received from NIH (scroll down to the end of this post to read it):

__________________________

April 11, 2016

Dear Public Liaison staff,

Thank you for your response to my letter concerning bias among investigators involved in the NIH study on ME/CFS. You have crafted a reassuring response without actually addressing my point.

My point is not that there is potential bias, but that your lead clinical investigator Dr. Brian Walitt is, in fact, biased. His bias has been expressed in a number of publications, as well as in an interview last September. Dr. Walitt believes that patients with fibromyalgia and related illnesses, such as ME/CFS, "catastrophize," that they exaggerate their symptoms, and that their disease has psychogenic origins, specifically in child abuse.

Psychogenic theories are a remnant of Freudian psychology, in which various disease states, including MS and gall bladder disease, among others, were attributed to childhood abuse. There is no scientific evidence to support these theories, nor will there ever be. Science demands the rigor of controlled studies, and a limitation of confounding variables. It also demands baseline measurements. The psychogenic claims espoused by Dr. Walitt have not conformed to these basic tenets of science. Instead they have merely echoed an increasingly outmoded style of thinking. His inclusion in this study is not only unfathomable, it is an embarrassment.

If this were a study on the biological origins of Alzheimer's disease, ALS, or Parkinson's, would you place someone in a position of authority who believed that these diseases were caused by childhood abuse, or that the patients were "catastrophizing" or exaggerating their symptoms? It would be absurd to include someone with such views, and equally absurd to claim that someone holding those views would not affect the study.Dr. Walitt has no place in this study. Neither does Dr. Gill, who holds similar views, nor Dr. Saligan who has jointly published papers with Dr. Walitt espousing psychosomatic theories. If Dr. Collins is serious about studying this disease, as he has so often stated, he should show his commitment by appointing people to positions of authority who are actual experts.

Sincerely,

Erica Verrillo

______________________

Dear Ms. Verrillo:

Your email to the National Institutes of Health (NIH) ME/CFS Trans-NIH Working Group concerning myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has been forwarded to this Institute for reply.

We are pleased that you were able to join us for the NIH telebriefing on ME/CFS last month.You expressed concern about potential bias among the investigators who will be involved with the new ME/CFS study at the NIH Clinical Center in Bethesda, Maryland. Please know that the investigators have a keen interest in finding answers and life-changing treatments for people with ME/CFS. The study protocol is designed to prevent any possible bias from affecting the results, and the large group of associate investigators, combined with the collaboration and oversight of the Executive Committee, should also help to ensure this. We have utmost confidence in the dedicated, multidisciplinary team that will conduct this study, and we sincerely believe that the combined resources and expertise of the NIH will shed light on a previously unsolved medical puzzle.

If you have not already done so, you may wish to visit the Trans-NIH ME/CFS Working Group website at http://www.nih.gov/mecfs/about-mecfs.This site will serve to keep people informed about the Working Group’s activities.The site includes FAQs about trans-NIH research on ME/CFS, reports from past ME/CFS workshops and meetings, and links to resources on ME/CFS for researchers and patients.

Thank you for your comments.We at the NIH are confident that the new clinical study and other initiatives will support the efforts of the scientific experts who are working on this very challenging disorder and will encourage rapid scientific progress and the development of new ways to diagnose and treat ME/CFS.

We hope this information is helpful.

Office of Communications and Public Liaison,National Institute of Neurological Disorders and Strokeon behalf of the Trans-NIH ME/CFS Working Group

April 1, 2016. Today, the Director of the National Institutes of Health, Dr. Francis Collins, announced that an upcoming NIH study on chronic fatigue syndrome would be cancelled, due to an unexpected breakthrough by its lead clinical investigator Dr. Brian Walitt.

The breakthrough came after a painstaking review of several thousand research studies in the PubMed database, which revealed the true nature of the disease.

"It was there all along," said Dr. Collins. "But it took the eye of an expert clinician to find it."

Chronic fatigue syndrome, according to the NIH, is a complex, multi-system disease that affects nearly every part of the body and produces a plethora of symptoms. The wide array of symptoms, as well as the involvement of the nervous, immune and endocrine systems, have baffled scientists for decades. The question the scientific community could not answer was how one disease could produce so many effects.

"That's just it," said Dr. Walitt. "When we looked carefully, we found that not only did people with CFS have cytokines, neurochemicals, hormones, and red blood cells, but everyone else did too!"

This shocking revelation led to another ground-breaking finding.

"People with CFS have all the major organs that other people have," said Dr. Walitt. "They have arms, legs, torsos, and, in the vast majority of cases, faces, and these commonalities are found across the board. People with CFS have ALL THE THINGS. What's more, they have all these things, and these things that they have are also in their heads, which are attached to their bodies, which is true of everyone else as well. It's a narrative that encompasses all of culture and society."

"Dr. Walitt's findings will have an enormous impact on how we do science," said Dr. Collins.

On the heels of its cancellation of the CFS study, the NIH also announced that it would be closing down all of its Institutes, in favor of a single Institute : the Institute of Biopsychosocialculturalneuroendocrineimmune Syndromes.

"Having only one Institute will revolutionize how we do research in the future," said Dr. Collins. "From now on we will devote all our efforts to investigating BS."

Author

PLEASE HELP PEOPLE WITH CFS/ME FIND THIS WEBSITE! Click "like" on any page. Thank you!

About me:I'm a 25-year veteran of CFIDS. I know what it is like to be bedbound for long stretches of time. I also know what it is like to recover, and to relapse. But this blog is not about my personal experience. It is intended to be a resource - a collection of anything that might be helpful to the CFIDS community: book reviews, advice, CFIDS news, research, advocacy, opinion, who's who in our community, fundraising... and occasionally a bit of humor.

Disclaimer: I am not a doctor, which means nothing I write, no matter how sensible it may be, should be interpreted as medical advice.